Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis
Status:
Terminated
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of
various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of
the abdominal wall, either through primary closure or with a synthetic graft when primary
closure is not feasible.
It has been established that bowel function after repair of gastroschisis is impaired due to
the aforementioned pathological processes. Previous studies have shown that the time from
surgery to attaining full nutrition through enteral means is a predictor for morbidity in
this population. Therefore, numerous therapeutic interventions have been proposed to help
hasten bowel function and decrease the time to tolerance of total enteral nutrition. A
common, but unproven, technique is the use of glycerin suppositories to stimulate bowel
function. The concept of glycerin suppositories is that stimulating colonic activity through
the use of the suppository will stimulate small intestinal function. The underlying concept
is that improved bowel motility and reduced time to full enteral feeds will reduce the
morbidity associated with this disease. While the formation/evacuation of stools is most
easily monitored, the main purpose of using these suppositories is to hasten tolerance of
nutrition through enteral means.
While the practice of using glycerin suppositories is common in neonates, there is no
literature or best-practice guidelines advocating for (or against) their use. A single
previous prospective study utilizing glycerin suppositories in premature, low birth weight
neonates failed to show any benefit in improving time to tolerate full enteral feeds. At this
time, this is the only study investigating the use of glycerin suppositories in any neonatal
population, and due to the indications (i.e. premature and low birth weight infants without
surgical disease), the findings are not applicable to neonates with gastroschisis. To the
authors' knowledge, there are no previous studies or current ongoing studies examining this
question. Given this lack of information regarding the efficacy of glycerin suppositories,
there is a significant variation in practice among practicing surgeons, including timing of
initial administration, frequency of use, and indication to discontinue. Indeed the spectrum
ranges from some surgeons who never use glycerin suppositories, to some who prescribe them
daily for all gastroschisis patients immediately following surgery.
The purpose of this study will be to determine whether routine use of glycerin suppositories
improves bowel function as measured by time to full enteral feeds (primary outcome: defined
as enteral feed volume >120mL/kg/day with appropriate weight gain (20-30g/day for two
consecutive days)) in neonates with uncomplicated gastroschisis after complete reduction of
abdominal viscera. Secondary outcomes include time to first bowel movement and
incidence/severity of TPN-induced cholestasis in the study groups.
Phase:
Phase 4
Details
Lead Sponsor:
Indiana University
Collaborators:
Alan Ladd, M.D. Robert Vandewalle, M.D. Teresa VanHorn